Speaker


From the Agenda

Panel

2016-11-22 14:20:00

Narayanan Gopalan

Vice President

Dr Narayanan qualified as a physician and has dual specialist postgraduate qualification in general internal medicine and pharmaceutical medicine. He has substantial experience in the area of biologics, advanced therapies and biosimilars. As Vice President and Head of Biologics at Voisin Consulting Life Sciences, he provides advice and guidance on product development and regulatory science aspects of Biologics and Advanced Therapies. He worked at UK MHRA during 2001 – 2013 and was Head of the Biotechnology unit and Expert Medical Assessor. He was a member of the Committee for Advanced Therapies (EMA/CAT 2009 – 2013), Scientific Advice Working Party (CHMP/SAWP 2009 - 2013) representing EMA/CAT, Biosimilar Working Party (EMA/BMWP) and Gene Therapy Working Party (CAT/GTWP). He has extensive regulatory experience dealing with marketing authorisations and scientific advice procedures in the EU and UK. He has been rapporteur for several guidelines and has several publications in the area of biological medicinal products, particularly gene and cell therapies and presented regularly at international conferences by organisations such as DIA, BIO, and Phacilitate etc. His prior experience includes working at Reckitt Benckiser, UK and Chiron Corporation, CA, USA. He is on the scientific editorial board of Human Gene Therapy Clinical Development journal.